Kornimate/medical-research-clean huggingface dataset:
a study of carboplatin and gemcitabine plus bevacizumab in patients with ovary, peritoneal, or fallopian tube carcinoma

Conditions: Ovarian Cancer

Summary: this is a placebo-controlled, randomized, multicenter phase iii study that will evaluate the safety and efficacy of bevacizumab, administered in combination with carboplatin with gemcitabine, in women with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.


Eligibility criteria:
inclusion criteria: * signed informed consent form * age ≥ 18 years * documented ovarian, primary peritoneal, or fallopian tube carcinoma that has recurred * no prior chemotherapy in the recurrent setting * measurable disease * recovered from prior radiation therapy or surgery exclusion criteria: * prior chemotherapy treatment for recurrent ovarian, primary peritoneal, or fallopian tube carcinoma * history of abdominal fistula, gastrointestinal perforation (gip), or intra-abdominal abscess * patients with clinical symptoms or signs of gastrointestinal (gi) obstruction or who require parenteral hydration, parenteral nutrition, or tube feeding * patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure * current, recent, or planned participation in an experimental drug study * history of systemic bevacizumab (avastin) or other vascular endothelial growth factor (vegf) or vegf receptor-targeted agent use * inadequately controlled hypertension * prior history of hypertensive crisis or hypertensive encephalopathy * new york heart association class ii or greater congestive heart failure (chf) * history of myocardial infarction or unstable angina * history of stroke or transient ischemic attack (tia) * known central nervous system (cns) disease except for treated brain metastasis * significant vascular disease or recent peripheral arterial thrombosis * history of hemoptysis * evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)

Keywords: avastin ovarian carcinoma peritoneal carcinoma peritoneal cancer fallopian tube cancer fallopian tube carcinoma oceans
clg561 proof-of-concept study as a monotherapy and in combination with lfg316 in subjects with geographic atrophy (ga)

Conditions: Geographic Atrophy

Summary: the purpose of this study is to evaluate the safety and efficacy of 12 (every 28 days) intravitreal (ivt) injections of clg561 as a monotherapy and in combination with lfg316 as compared to sham in subjects with geographic atrophy.

this study consists of an up-to 30-day screening period, an approximately 336-day treatment period, and a follow-up period consisting of two visits occurring 4 and 16 weeks after the last administered injection.

Eligibility criteria:
inclusion criteria: * sign written informed consent form; * geographic atrophy in both eyes; * other protocol-specified inclusion criteria may apply. exclusion criteria: * pregnant or lactating women and women of child-bearing potential; * any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in this study; * any contraindications or hypersensitivities to any component of the lfg316 or clg561 solution; * any contraindications to ivt injections; * ocular surgery in either eye within 90 days of screening; * uncontrolled ocular hypertension or glaucoma in the study eye; * other protocol-specified exclusion criteria may apply.

Keywords: geographic atrophy (ga) macular degeneration dry age-related macular degeneration (amd) intravitreal (ivt) retinal diseases fundus auto fluorescence (faf)
effectiveness of 'supportive parenting app' on parental and newborn outcomes

Conditions: Postnatal Depression; Self Efficacy; Parent-Child Relations; Development, Child; Anxiety; Parenting Satisfaction

Summary: the supportive parenting app is a theory-based perinatal educational intervention for couples administered through a mobile application. the intervention comprise of knowledge-based content, informational videos and audio, discussion forum, peer volunteer chat group, and a frequently asked questions (faq) expert advice section. the aims of the study are to: 1. develop theory-based supportive parenting app (spa) intervention for both first-time and experienced parents across perinatal period 2. examine its effectiveness on parental outcomes: including maternal depression at 12 months postpartum (primary outcome), paternal depression, parental anxiety, parenting self-efficacy, help - seeking behavior (social support), parental bonding and parenting satisfaction (secondary outcomes); and new-born outcomes: physical, social and emotional developments (secondary outcomes) 3. evaluate spa's cost-effectiveness as compared to standard perinatal care across major restructured hospitals, and 4. examine the perceptions of parents in receiving this intervention. when compared with those in the control group receiving standard care: 1. parents receiving spa intervention will have better- emotional well-being (reduced depression and anxiety);parenting self-efficacy; social support; bonding and satisfaction. 2. new-borns of parents receiving spa will have better physical, social and emotional development 3. it will be more cost-effective to provide spa than the standard care


Eligibility criteria:
inclusion criteria: * able to read and speak english * have low-risk singleton pregnancy with more than 24 weeks of gestation (age of viability) * have smartphone with internet access exclusion criteria: * have physical or mental disorders which would interfere with their ability to participate in the study * have high-risk pregnancy including placenta-previa major, pre-eclampsia, pregnancy induced hypertension etc. * have complicated assisted delivery such as vacuum or forceps with 4th degree perineal tear of the mother; and /or * give birth to a newborn at still-birth or a newborn with congenital anomalies and/or medical complications including pathological jaundice, that required special care in hospital.
bonefos and the consumption of analgesics

Conditions: Bone Neoplasms

Summary: the effect of bonefos on consumption of analgesics (drugs used for pain treatment) in patients with proven bone metastases.


Eligibility criteria:
inclusion criteria: * breast cancer or prostate cancer or multiple myeloma. * bone metastasis. * ability to use analgesics and clodronate 1600 mg/day. exclusion criteria: * hypersensitivity to bisphosphonates. * clodronate in previous therapy. * concomitant use of other bisphosphonates. * serious renal insufficiency.

Keywords: breast cancer prostate cancer multiple myeloma
primary debulking surgery including bowel resection in advanced stage ovarian cancer using caiman® technology

Conditions: Ovarian Cancer

Summary: longitudinal prospective study on primary debulking surgery including bowel resection in advanced stage ovarian cancer patients using caiman® technology

using caiman® technology in primary surgery for advanced ovarian cancer including bowel resections. analyze potential time-sparing and the incidence of post-surgical complications. prospective, longitudinal, observational. 40 patients / year.

Eligibility criteria:
inclusion criteria: * age ≤ 75 years * patients with advanced ovarian cancer (figo stage iiic-iv). * bowel resection * class 0-2 according to the american society of anesthesiologists (i.e.: asa score ≤ 2) * written informed consent to the study exclusion criteria: * pregnant or chronic infections * previous pelvic radiotherapy

Keywords: advanced ovarian cancer
vessel imaging using optical coherence tomography for plaque morphology and vessel fractional flow reserve

Conditions: Coronary Artery Disease; Coronary Artery Stenosis; Tomography, Optical Coherence; 3D-angio-based FFR

Summary: the aim of this prospective, investigator-initiated study is to evaluate the diagnostic accuracy and correlations between mopphometric indices: luminal and qualitative parameters assessed by optical coherence tomography (oct) including minimal lumen area, plaque type, presence of thin cap fibroatheroma and a functional index - angiography based vessel fractional flow reserve (vffr) among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.

this is a prospective, single center, non-randomized, single-arm, investigator-initiated study evaluating diagnostic accuracy and correlations between morphometric indices: luminal and qualitative parameters evaluated by optical coherence tomography (oct) including minimal lumen area, plaque stratification into fibrotic, calcific, lipidic plaque, or thin cap fibroatheroma and a functional index - angiography based vessel fractional flow reserve (vffr) among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis. the additional objectives encompass assessing the influence of age, sex, diabetes mellitus, renal dysfunction on the relationship between vffr results and morphometric indices of intermediate coronary stenosis. we hypothesized that in patients with intermediate grade coronary stenosis in chronic coronary syndrome a positive correlation exists between vffr and the morphometric parameters associated with coronary stenosis.

Eligibility criteria:
inclusion criteria: * 18 years or older * chronic coronary syndrome defined as presence of chest pain ranked 2-3 in the canadian cardiovascular society classification or positive ischemia test (exercise test, single photon emission tomography (spect) * intermediate grade coronary stenosis of 40-80% assessed visually in coronary angiography and oct examination the patient is willing to participate in the study and has provided a written informed consent exclusion criteria: * acute coronary syndrome * proximal left main lesion * ostial right coronary artery lesion * bypass of the assessed vessel * contraindications for adenosine administration * hemodynamic instability * heart insufficiency in new york heart association (nyha) class iv scale * acute renal insufficiency * pregnancy
role of myostatin, activin a and follistatin cachexia of ent cancers

Conditions: Cachexia; Squamous Cell Carcinoma; Head and Neck Cancer

Summary: the main objective of our study was to determine the modifications of blood myostatin and activin a concentrations associated with head and neck cancers. secondary objectives consisted in studying their influence on the occurrence of cachexia, bringing the proof of a tumoral secretion of these factors, and then determining the effect of tumor removal.

myostatin and activin a, two members of the superfamily tgf-β, have been shown to play a role on skeletal muscle mass regulation. in humans, high plasma concentrations of activin a were observed in cancer patients, especially in cachectic subpopulations, suggesting their involvement in the development of cachexia. 55 patients were included in the study : 32 in the cancer group (only squamous cell carcinoma) and 23 in the control group. the patients underwent a complete nutritional assessment and multiple samples : blood before and 7 days after surgery, skeletal muscle biopsies, tumor biopsies. plasma concentrations of myostatin, activin and follistatin were measured before and after tumor removal surgery. concentrations of myostatin, activin and follistatin were also measured in an incubation medium of a tumor biopsy. activin a and follistatin plasma concentrations were significantly increased in the cancer group (320 vs. 203 pg/ml ; p \<0.001) (3593 vs 2148 pg/ml ; p \<0.001), while myostatin plasma concentration was significantly decreased in this group (1542 vs. 2100 pg/ml ; p = 0.010). surprisingly, data of the 7th postoperative day showed an increase in plasma activin a concentration (379 vs 320 pg /ml ; p \<0.001) while concentrations of myostatin and follistatin were not modified. a high postoperative systemic inflammation is one hypothesis to explain these later results. myostatin, activin a and follistatin proteins were systematically detected in the medium of tumor a 48 hour-incubation period, providing a strong proof of the tumor production of these factors by squamous cell carcinoma. the activin a/myostatin/follistatin is modified in the context of head and neck cancer. activin a particularly seems to play a role in the occurrence of cachexia while follistatin could have a protective role for skeletal muscle mass. this system could aimed in therapeutic ways to reduce cachexia in a context of cancer in order to improve the quality of life and survival of patients.

Eligibility criteria:
inclusion criteria: for case group : * head and neck cancer * squamous cell carinoma only * head and neck surgery chosen as treatment of cancer * age 18-75 for control group : * neck surgery for non oncologic disease * age 18-75 exclusion criteria: * heart failure, respiratory failure (requiring a long-term oxygen therapy), chronic renal failure (mdrd clearance \< 60 ml/min), moderate or severe chronic obstructive pulmonary disease and insulin-dependent diabeta for the two groups * cachexia for control group

Keywords: activin a myostatin follistatin cachexia squamous cell carcinoma
investigational drug versus an approved drug in patients with rheumatoid arthritis (0663-072)

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the long-term safety of an investigational drug versus an approved drug for the relief of pain in patients with rheumatoid arthritis.

the duration of treatment is 12 months.

Eligibility criteria:
inclusion criteria: * males and females 50 years or older with rheumatoid arthritis. exclusion criteria: * history of gastrointestinal malabsorption or inflammatory bowel disease * history of heart problems such as: congestive heart failure (chf), heart attack or high blood pressure.

Keywords: arcoxia
study of the protective effect of an injectable influenza vaccine against influenza illness in adults under 50 y.o.

Conditions: Influenza

Summary: the goal of this study is to determine whether fluviral, an inactivated, injectable trivalent influenza vaccine (flu shot) is effective in preventing respiratory illnesses that are severe enough to limit normal daily activities and that are shown by virus culture to be caused by influenza viruses. the study will also examine the safety of the vaccine and collect measurements of the immune system responses produced by the vaccine.

yearly influenza (flu) epidemics cause a large burden of lost work and school time among younger persons and excess hospitalizations and deaths among the elderly. injectable flu vaccines are generally believed to be effective, but formal studies using modern culture methods to prove this are limited. this study will compare the rate of respiratory illnesses associated with positive influenza virus cultures in healthy younger adults (a group at low risk for serious influenza complications) who have received fluviral (an injectable flu vaccine) with the rate of such illnesses in healthy younger adults who have received an injection of saline (salt water). the rate of local vaccine reactions and other symptoms will be compared between the vaccine and salt water groups, and the immune responses to the vaccine measured.

Eligibility criteria:
inclusion criteria: * good health by history and physical exam * reliable access to a telephone * study comprehension and informed consent exclusion criteria: * systolic bp \>/= 140; diastolic bp \>/= 90 * uncontrolled medical or psychiatric illness (change in last 3 months) * cancer, or treatment for cancer within 3 years * cardio-pulmonary disease requiring chronic treatment * insulin dependent diabetes mellitus * renal dysfunction (creatinine \>/= 1.7 mg/dl) * hemoglobinopathies * clotting disorders that increase the risk of im injections * immunosuppressive illnesses or drugs * history of demyelinating disease (esp. guillian-barre syndrome) * employment in professions at high risk for influenza transmission * household contact with high-risk individuals * receipt of: a) immunosuppressive drugs i) systemic glucocorticoids \>/= 10 mg prednisone per day ii) cytotoxic drugs b) investigational drugs within 30 days before, or planned during, the study c) blood products within 3 months before, or planned during, the study d) influenza vaccine within 9 months before the study e) other vaccines within 30 days before, or planned during, the study * history of: 1. severe reactions to other influenza vaccines 2. allergy to egg proteins 3. sensitivity to mercurials * pregnancy/ high risk of pregnancy 1. positive urine pregnancy test before treatment 2. women of child-bearing potential without credible contraceptive plan

Keywords: influenza vaccine efficacy safety immunogenicity
effect of lifestyle on caries and apical periodontitis

Conditions: Apical Periodontitis; Caries; Lifestyle; Inflammation; Endodontics

Summary: this study aimed to link lifestyle factors (mediterranean diet adherence, stress, sleep quality, physical activity) to caries and apical periodontitis in 149 university-based individuals. data included clinical and radiographic assessments and lifestyle questionnaires. statistical tests and logistic regression were employed to analyze the relationships between these factors and oral health conditions.

the aim of this study was to evaluate the association between lifestyle (adherence to the mediterranean diet, stress, sleep quality, and level of physical activity) with the presence of caries and apical periodontitis (ap) in a university-based cohort of individuals. a total of 149 patients were included in this cross-sectional study. in addition to clinical (cold test, percussion test, evaluation of tooth mobility) and radiographic (bitewing rx, periapical rx, and opt) parameters, validated questionnaires were used to investigate patient's lifestyle. data on the number of decayed, missing, and filled teeth (dmft score) and the severity of apical periodontitis (pai score) were extrapolated from the available clinical and instrumental investigations. shapiro-wilk test was used to evaluate the normal distribution of data; wilcoxon rank-sum test (mann-whitney) was used to compare continuous variables. fisher's test was used to compare dichotomized variables. a logistic regression model was performed for the multivariate analysis.

Eligibility criteria:
inclusion criteria: * age between 18 and 70 * good general health status; * ability and willingness to give written consent; * presence of at least 6 teeth. exclusion criteria: * age \<18 years; * pregnancy or lactation; * administration of antibiotics within the last 6 months; * inability and unwillingness to give written consent

Keywords: apical periodontitis caries inflammation endodontics lifestyle
predictive model for high-flow nasal cannula failure in covid-19-related acute hypoxemic respiratory failure based on metabolomics and clinical data

Conditions: Acute Hypoxemic Respiratory Failure; COVID 19

Summary: the aim of this prospective observational cohort study is to develop a predictive model for high-flow nasal cannula (hfnc) failure in patients with acute hypoxemic respiratory failure (ahrf) caused by sars-cov-2. by combining clinical data and metabolomic profiles, the study seeks to answer: - can integrating clinical parameters with metabolomic markers enhance the prediction of hfnc failure in ahrf patients? participants with ahrf due to sars-cov-2 receiving hfnc under standard-of-care protocols will be monitored until hospital discharge or death. blood samples for metabolomic analysis will be collected at inclusion.

this prospective observational cohort study focuses on developing and validating a predictive model for hfnc failure in patients with sars-cov-2-related ahrf, combining clinical parameters and metabolomic profiling. patients received standard-of-care therapy based on hospital protocols, with clinical data and plasma samples collected at inclusion (t0) for laboratory and metabolomic analyses. the study consists of two cohorts: a training cohort (march 2020 to april 2021) for model development and a validation cohort (may 2021 to october 2021) for model validation and external testing. hfnc outcomes were classified as success or failure, with failure defined as requiring orotracheal intubation (oti). advanced machine-learning techniques were employed for feature selection and model optimization, targeting precise integration of clinical and metabolomic data. this model seeks to enhance early identification of hfnc failure risk, enabling timely interventions and personalized management in critically ill ahrf patients.

Eligibility criteria:
inclusion criteria: * adult patients (≥18 years old) with acute hypoxemic respiratory failure (ahrf) confirmed as secondary to sars-cov-2 infection via pcr testing. * requirement for high-flow nasal cannula (hfnc) initiated within 48 hours of hospital admission. exclusion criteria: * patients under the age of 18 * patients with active "do not resuscitate" (dnr) orders at the time of inclusion.

Keywords: acute hypoxemic respiratory failure covid-19 high-flow nasal cannula predictive model machine learning metabolomics
effect of rib mobilization on weaning parameters from mechanical ventilator in patients with pneumonia

Conditions: Pneumonia

Summary: this study will be conducted to distinguish between effect of rib mobilization and routine chest physiotherapy on weaning parameters from mechanical ventilator in patients with pneumonia • hypotheses: it will be hypothesized that there may be significant effect of rib mobilization on weaning parameters from mechanical ventilator in patients with pneumonia. research question: does rib mobilization have an effect on weaning parameters from mechanical ventilator in patients with pneumonia? measuring weaning parameters: on screen of mechanical ventilator : measuring respiratory rate, tidal volume (tv), fio2. * arterial blood gases (abg) analyzer machine abg is recorded daily (ph- pao2 - paco2) * length of icu stay: calculated by (admission date - discharge date * weaning success rate

ventilator-associated pneumonia (vap) represents a significant sub-set of (hap) remains the most frequent intensive care unit (icu)-acquired infection its incidence ranges from 9% to 27% of ventilated patients ,vap is associated with an increased length of stay, mortality and health care costs, pneumonia can result in chest wall stiffness, decreased mobility, limiting the range of motion during breathing and decreased lung compliance and impaired respiratory function , rib mobilization: is an articular , non-invasive, passive technique that can be useful with acutely ill, hospitalized patients emphasizes the placement of a repetitive force to increase the range of motion of the posterior rib articulations and chest wall , lessening somatic dysfunction of the spine, stretches myofascial structures and improve respiratory mechanics so, this study will be conducted to distinguish between effect of rib mobilization and routine chest physiotherapy on weaning parameters among intubated pneumonic patients on mechanical vent.

Eligibility criteria:
inclusion criteria: 1. patient's age ranged from 40- 50 years old from both genders. 2. diagnosed with pneumonia and need invasive mechanical ventilation support. 3. stable oxygen saturation (spo2 more than 85, (fio2) 0.6 or less, peep less than 10 cm h2o). 4. mean arterial pressure \> 75 mmhg and urine output \> 1 ml/kg/h; 5. patients with glasgow coma scale (gcs) \> 8t 6. unconscious and semi-conscious patients. - exclusion criteria: 1. unstable hemodynamics 2. unstable neurological problems e.g. (epileptic seizures -hyperthermia). 3. unstable chest wall e.g. (multiple rib or vertebral fractures) 4. increase intracranial pressure (\>20 mmhg for \>5 min). 5. undrained pneumothorax, recent pulmonary surgery